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A Drug Safety Associate is a significant part of the pharmacovigilance industry. A Drug Safety Associate mainly monitors the safety of pharmaceutical drugs.
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Clinical Research and PharmacovigilanceCourses Create Efficient Drug Safety Associates https://www.technobridge.in/
Clinical Research Courses • Introduction: • Clinical Research • Significance of Drug Safety Associate • Processing an Adverse Event • Reporting the Cases to Regulatory Authorities • Collaborations with Other Teams https://www.technobridge.in/
Clinical Research Courses • Clinical Research Courses: https://www.technobridge.in/
Clinical Research Courses • Significance of Drug Safety Associate • A Drug Safety Associate is a significant part of the pharmacovigilance industry. • A Drug Safety Associate mainly monitors the safety of pharmaceutical drugs. • Their role in the industry is of great significance as they evaluate and prevent adverse reactions. • Once, pharmacovigilance professionals declare that a particular drug or device is safe for patients. • These drugs enhance the quality of the life of patients all over the world. • Given below are the different tasks that Drug Safety Associates execute in the pharmacovigilance industry. • Clinical Research courses give you an overall understanding of the tasks of Drug Safety Associates https://www.technobridge.in/
Clinical Research Courses • Processing an Adverse Event • The role for a Drug Safety Associate begins after the alert of a Serious Adverse Event. • These professionals immediately start completing the necessary tasks involved in processing an event. • Suppose, there is a life threatening case or a death, Drug Safety Associates are given 1-2 days to process the essential information. • There may be other cases such as hospitalization, significant disability, congenital anomaly. • In this case, the Drug Safety Associates would take 2-7 days to process the event. • The best clinical research training institutes give students an insight into several adverse events during clinical research courses. https://www.technobridge.in/
Clinical Research Courses • Reporting the Cases to Regulatory Authorities • In this short period of time, DSAs usually have to classify the case, ensure all the key information is correct, enter the information in the database and send the case for quality review. • Furthermore, they should proceed to the medical review stage and create queries to obtain information in order to accurately assess the role of the study drug on the event. • Finally, it’s important to deliver the case to the regulatory team so they can submit it to the relevant authorities such as the FDA or EMA and to investigators, ethics committees and IRBs. • This process can be more complex because DSAs are working on multiple projects with different Sponsors. https://www.technobridge.in/clinical-research-course.html https://www.technobridge.in/
Clinical Research Courses • Collaborations with Other Teams • Drug Safety Associates receive a variety of support both from their own study team colleagues and the other departments. • They have internal interactions with the Drug Safety Physicians (DSPs) for medical assessment of safety cases. • In a nutshell, the role of a drug safety associate is of great significance in the clinical research and pharmacovigilance industries. • After completing their clinical research courses, they play an important role in determining the safety and efficiency of drugs and devices. • Apart from that, they process Adverse Events and report them to regulatory authorities. https://www.technobridge.in/ https://www.technobridge.in/
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